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Regulatory News | 18 February 2016 | By Zachary Brennan
[Editor's note on 2/19/16: FDA spokesman Stephen King has since offered additional comment though he could not confirm whether or not this comment applies to Zhejiang Hisun or what the company has done to ensure that the API it's allowed to send to the US is not manufactured in the same way as the APIs that are banned from entering the US.
"When FDA exempts certain drugs
from an import alert due to shortage concerns, the agency also often requests
the manufacturer to take certain measures to enhance quality oversight for
products that are offered for entry into the United States. For example,
manufacturers often agree to modify their manufacturing processes, implement
additional in-process or finished product testing, and/or hire independent
auditors with CGMP expertise to certify the quality of batches offered for
The US Food and Drug Administration (FDA) on Thursday said it will allow the import of a chemotherapy’s active pharmaceutical ingredient (API) from China’s Zhejiang Hisun Pharmaceutical Co. because of concerns of a shortage.
Zhejiang Hisun is still under an import alert, which was first established in September 2015 and means all other API products sent to the US are banned entry. The alert came three months before a warning letter, which cited the company for numerous data integrity violations.
Among the most egregious observations from a Form 483 issued after an August inspection were data manipulation findings, in addition to the company’s failure to locate a logbook documenting the manufacture of APIs, as well as missing data from individual equipment logs.
FDA said in the updated alert from Thursday: “Only the API Daunorubicin HCl (NDC 58623-0046) for the Daunorubicin liposomal application (NDA# 50704) [marketed in the US as DaunoXome] has critical drug shortage concern and excluded from DWPE [Detention Without Physical Examination]. Shipments destined to any other manufacturer should be detained as per the Import Alert."
According to FDA’s drug shortage list, Teva Pharmaceuticals and Bedford Laboratories also supply Daunorubicin HCl solution for injection, though Bedford says its product is unavailable, while Teva says it does not anticipate any supply issues.
“The exemption from the import alert for Daunorubicin HCl was done temporarily, to address a potential shortage in the supply of a medically necessary drug in the US market,” FDA spokesman Stephen King told Focus. “It was in shortage in the past and that shortage was resolved in 2015. With this exemption we hope to prevent any further shortage, however, if it were to go into shortage again, at that point we would update our current shortage list with that information.”
FDA did not respond to a request for comment on how it would ensure the quality of Daunorubicin HCl made by Zhejiang Hisun is different from the other APIs that are not allowed in the US.
Tags: chemotherapy shortage, import alert, Daunorubicin HCl